Effectiveness of the transverse thoracic muscle plane block in adult cardiac surgery: a double-blind randomized clinical trial
Summary description of the study
Patients undergoing heart surgery via sternotomy experience moderate to severe pain after the operation, which may increase the dose of potent painkillers (morphine and derivatives) that have frequent side effects (nausea, vomiting, itching, respiratory failure). Furthermore, the management of high-dose administration occurs in an intensive care setting. This represents a barrier to rapid recovery and mobilization. In recent years, new techniques of locoregional anesthesia have been described for the treatment of post-operative pain. One of these techniques (transverse thoracic muscle plane block) is currently used at CHUV, but there are currently no data demonstrating its benefit in a larger patient cohort. We therefore wish to compare this technique to the so-called usual management.
(BASEC)
Intervention under investigation
- Effectiveness of adding locoregional anesthesia - the transverse thoracic muscle plane block - in addition to general anesthesia for patients benefiting from elective cardiac surgery with sternotomy
(BASEC)
Disease under investigation
- Adult patient requiring elective cardiac surgery with sternum incision (sternotomy) under general anesthesia
(BASEC)
- Direct informed consent as documented by signature - Major adult (≥ 18 years old) with body weight ≥ 50 kg. For the record, fifty kilograms is the minimal weight to ensure that participants remain safely away from maximal doses of LA (3 mg/kg) - Planned and primary cardiac surgery via a sternotomy approach - Planned for ultra-fast-track procedure (i.e. postoperative extubation time of maximum two hours) (BASEC)
Exclusion criteria
- Emergent cardiac surgery - Previous cardiac surgery - Known hypersensitivity or true allergy to bupivacaine and other amide-class LA (BASEC)
Trial sites
Lausanne
(BASEC)
Sponsor
CHUV
(BASEC)
Contact
Contact Person Switzerland
Etienne Revelly
+41795569990
etienne.revelly@clutterchuv.chCHUV 1011 Lausanne
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
28.10.2022
(BASEC)
ICTRP Trial ID
NCT05681507 (ICTRP)
Official title (approved by ethics committee)
Efficacy of TTMPB in Adult Cardiac Surgery (BASEC)
Academic title
Efficacy of Transversus Thoracic Muscle Plane Block in Adult Cardiac Surgery: A Randomized Controlled Trial (ICTRP)
Public title
Efficacy of TTMPB in Adult Cardiac Surgery (ICTRP)
Disease under investigation
Acute Post Operative Pain (ICTRP)
Intervention under investigation
Drug: Transversus thoracic muscle plane block;Procedure: Standard postoperative analgesia (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Direct informed consent as documented by signature
- Major adult (= 18 years old) with body weight = 50 kg. For the record, fifty kilograms
is the minimal weight to ensure that participants remain safely away from maximal
doses of LA (3 mg/kg)
- Planned and primary cardiac surgery via a sternotomy approach
- Planned for ultra-fast-track procedure (i.e. postoperative extubation time of maximum
two hours)
Exclusion Criteria:
- Participation in another study with investigational drug within the 30 days preceding
and during the present study
- Refusal and/or inability to understand or sign the informed consent
- Emergent cardiac surgery
- Previous cardiac surgery
- Known hypersensitivity or true allergy to bupivacaine and other amide-class LA
- Chronic pain history
- Substance abuse history
- Inability to follow the procedures of the study (e.g. due to language problems,
psychological / psychiatric disorders, dementia)
- Clinically significant concomitant diseases: severe cardiac dysfunction (i.e. LVEF =
35%); severe chronic obstructive pulmonary disease (i.e. FEV < 50%); severe hepatic
disease.
- Severe obesity (BMI > 35kg/m2)
(ICTRP)
not available
Primary and secondary end points
Total amount (in mg) of opioid consumption within the first 24 hours (ICTRP)
not available
Registration date
13.12.2022 (ICTRP)
Incorporation of the first participant
01.12.2022 (ICTRP)
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
TTMPB-Heart Trial (2022-01126) (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/show/NCT05681507 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available